>10×5 ml 5% lipostabil (PCDC) $50 ONLY firstname.lastname@example.org
What are lipodissolve injections?
Lipo-dissolve injections have become an increasingly popular means to remove excess fat. The procedure goes by many names (e.g., Lipostabil®, Lipodissolve, Flab-Jab, Lipojection, Lipotherapy, etc.) and involves the injection of mixtures of various chemicals into the fat through multiple microinjections administered over multiple treatment sessions. The desired end result is the gradual removal of localized fat deposits. Lipo-dissolve injections are generally not regarded by medical professionals to be as potent as liposuction, a powerful yet invasive surgical procedure in which multiple liters of fat are ‘sucked’ from patients in a single session. Lipo-dissolve therapy typically requires that dozens of small ‘fat burning’ injections of compounded phosphatidylcholine/deoxycholate (PCDC) be injected into fat and connective tissue over several sessions. These drugs are not FDA-approved.
What are the compounds/ingredients in the injectable solution?
The main compound used in lipo-dissolve is phosphatidylcholine (PC), a compound derived from soy that is a component of cell membranes in many organisms, including humans.1solubilize phosphatidylcholine, thus keeping it in solution.1 Together, the main ingredients are commonly abbreviated as PCDC, however without a specific FDA-approved formulation for the injected solution, the ratio of the two compounds in a given formulation may be substantially different depending on the provider. Some providers also add small amounts of other medications, vitamins, and herbs. PCDC injections have not been approved by FDA for ANY indication and neither phosphatidylcholine nor deoxycholate are active ingredients in ANY FDA-approved drug. Deoxycholate (DC), a naturally occurring bile salt produced by the liver, is also used in the formulation to
Where do providers get the PCDC for lipo-dissolve injections?
The PCDC drug is obtained from compounding pharmacies, which traditionally make small quantities of unique drugs for specialized treatments (e.g., special versions of drugs for patients with allergic reactions). According to experts who discussed this issue with the Washington Post, in many situations involving compounded drugs, quality control and sterility can often be “spotty or nonexistent.”2
What is the standard lipo-dissolve procedure?
There is no standard process/procedure that has been studied in controlled clinical trials or to the satisfaction of the FDA. Therefore, the procedure will differ depending on the provider. FDA-approved drugs have a standardized drug formula and method of administration. With lipo-dissolve, individual providers determine dosing and technique. The lipo-dissolve procedure “typically” involves an average of 2-4 treatment sessions spaced 4-8 weeks apart.3According to the Aesthetic Surgery Journal, the maximum safe dose of PC is 100 mL per session with approximately 0.4 mL delivered with every micro-injection. However, because studies have not concluded a standard protocol outlining specific number of sessions, number of microinjections per session, and amount of PC needed for results, this average may vary greatly.4
How is the drug cleared from the body?
There is no scientific support for theories about how the drug is cleared from the body. It is unclear exactly how the body metabolizes and excretes the drug and the broken down fat cells. The injected chemicals are believed to trigger an inflammatory response as the fat cells are broken down and are thought to be excreted in the urine and feces. Without pharmacologic studies (those that study the compound’s mechanism of action and are required for FDA-approved drugs), these theories cannot be confirmed.
How long has the procedure been around? How many times has it been performed?
Cosmetic use of phosphatidylcholine injections was introduced at the First International Meeting of Mesotherapy in 1988 by Italian Physician Sergio Maggiori5. The formulation began being used for fat removal in Brazil in the 1990’s yet was later banned by ANVISA (Brazilian National Agency of Health Inspection). The procedure has only more recently been introduced in the U.S., and the American Society of Non-surgical Aesthetics estimates that 50,000 to 100,000 lipo-dissolve treatments have been performed in the USA and Europe6. Despite the numbers of treatments performed, the drug’s safety and efficacy cannot be confirmed without controlled clinical trials as required by the FDA.
I keep hearing different terms for the treatment (e.g., lipo-dissolve, advanced lipo-dissolve, lipotherapy, injection lipolysis, etc.), are they all the same thing?
The treatments are similar in that each typically involves the injection of an unapproved PCDC formulation.
What areas can be treated with injections?
Currently, people use PCDC in a variety of areas (chin, abdomen, thighs). However, no well-controlled studies have examined where in the body the drug may or may not work. There is no FDA-approval for this drug for any part of the body.
Does the phosphatidylcholine affect other cells in the body besides fat cells?
It is unknown whether the drug affects other cells in the body (such as muscle or nerve cells). While a “theory” has been proposed for the method by which phosphatidylcholine destroys fat cells, the scientific mechanism still is not well understood.7
Are the injections a proper treatment for weight loss?
Without FDA-approval, this answer is unknown. But according to lipo-dissolve providers, the answer is no. Lipo-dissolve is not a viable means to lose weight. The ideal candidate is at a healthy weight but possesses localized fat deposits that cannot be reduced by exercise and diet. Lipo-dissolve may be successful in reducing inches but may not show any reduction in actual weight.
Are the ingredients used for lipo-dissolve safe?
PCDC is an unapproved drug. According to physicians currently studying the procedure, “until more safety data becomes available, physicians may be placing patients at unknown risks as they become reliant upon a compounded formulation for these treatments.”8 Additionally, FDA has stated that “there are no FDA approved drugs with an approved indication to dissolve fat and FDA cannot assure the safety and efficacy of these types of drugs.”8